Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micromedics, Inc. — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
189 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241739 | Endoscopic Applicator, 41 cm | Micromedics, Inc. | 2024-07-15 | 28 | 0 |
| K123847 | MALLEABLE TIP ENDOSCOPIC APPLICATOR | Micromedics, Inc. | 2013-01-08 | 25 | 0 |
| K122526 | 360 GAS ASSISTED ENDOSCOPIC APPLICATOR | Micromedics, Inc. | 2012-11-16 | 88 | 0 |
| K120608 | ENDOSCOPIC APPLICATOR | Micromedics, Inc. | 2012-03-15 | 15 | 0 |
| K102563 | SINGLE CANNULA EXTENDED APPLICATOR | Micromedics, Inc. | 2011-03-15 | 189 | 0 |
| K100754 | GRAFT DELIVERY SYSTEM MODEL SA-6115 | Micromedics, Inc. | 2010-06-09 | 84 | 0 |
| K073401 | EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 | Micromedics, Inc. | 2008-03-14 | 101 | 0 |
| K061092 | BAXTER DUPLOSPRAY MIS APPLICATOR | Micromedics, Inc. | 2006-09-13 | 147 | 0 |
| K051157 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS | Micromedics, Inc. | 2005-09-01 | 119 | 0 |
| K050340 | MICROMEDICS SPHENOID SINUS STENT | Micromedics, Inc. | 2005-04-27 | 75 | 0 |
| K042834 | MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR | Micromedics, Inc. | 2005-02-11 | 121 | 0 |
| K033589 | BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR | Micromedics, Inc. | 2004-10-04 | 326 | 0 |
| K012868 | MICROMEDICS FIBRIJET AEROSOL APPLICATOR | Micromedics, Inc. | 2001-10-29 | 63 | 0 |
| K993234 | MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS | Micromedics, Inc. | 1999-11-10 | 44 | 0 |
| K991670 | SILVERSTEIN MICROWICK | Micromedics, Inc. | 1999-08-26 | 101 | 0 |
| K992138 | MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND A | Micromedics, Inc. | 1999-08-09 | 46 | 0 |
| K982667 | MICROMEDICS NASAL SEPTAL BUTTON | Micromedics, Inc. | 1998-11-24 | 116 | 1 |
| K940371 | SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP | Micromedics, Inc. | 1994-04-06 | 90 | 0 |
| K912418 | SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE | Micromedics, Inc. | 1991-12-20 | 203 | 0 |
| K911785 | RHINO-GUARD | Micromedics, Inc. | 1991-10-07 | 168 | 0 |
| K895738 | MICROMEDICS EAR, NOSE AND THROAT BURS | Micromedics, Inc. | 1989-12-19 | 84 | 0 |
| K895739 | MICROMEDICS SURGICAL DRILL SYSTEM | Micromedics, Inc. | 1989-10-13 | 17 | 0 |
| K883338 | SURGICAL SEALANT APPLICATOR | Micromedics, Inc. | 1988-08-23 | 14 | 2 |
| K881020 | SURGICAL SEALANT DISPENSER (SSD) | Micromedics, Inc. | 1988-03-25 | 15 | 1 |
| K860940 | MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT | Micromedics, Inc. | 1986-05-02 | 51 | 0 |
| K842212 | MICROMEDICS SURGICAL INSTRUMENTS | Micromedics, Inc. | 1984-10-01 | 119 | 0 |
| K832068 | CODY SACCULOTOMY TACK | Micromedics, Inc. | 1983-10-19 | 114 | 0 |
| K832680 | MICRO-EDGE DISPOSABLE BLADES | Micromedics, Inc. | 1983-10-14 | 66 | 0 |
| K830228 | OTOLOGICAL VENTILATION TUBES-VARIOUS | Micromedics, Inc. | 1983-03-07 | 42 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda